Effects of Acupuncture on Body Mass Index in Overweight and Obese Women With Polycystic Ovary Syndrome (PCOS )

Peking University

Status: Completed

Conditions: PCOS; Overweight; Obesity

Treatments: Other: Sham acupuncture; Other: Lifestyle management; Other: Active acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04193371

PekingUTH TCM

Details and patient eligibility

About

This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic dysfunction in overweight and obese women with PCOS, and further exploring the alteration of lipidomics, bile acid omics, proteomics and branched-chain amino acids between PCOS and the normal controls, and before and after the acupuncture treatment in different gourps.

Full description

Polycystic ovary syndrome (PCOS) affects 6 to 18% of all women and is the most common female endocrine and metabolic disorder during the reproductive years. PCOS is characterized by anovulation, hyperandrogenism and metabolic dysfunction.Obesity is ~40% higher in women with PCOS than in healthy women. Overweight results in irregular cycles, insulin resistance and infertility. Acupuncture is assumed to reduce weight The overall hypothesis is that if the Body mass index (BMI) decreased, ovulation can be induced, hyperandrogenism decreased, and insulin sensitivity improved in these women. Although several treatment strategies have shown efficacy, importantly, there is a need for Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Therefore, the investigators aim to compare the effect of acupuncture, with usual care (lifestyle management) for weight loss, and improvement and prevention of reproductive and metabolic dysfunction in overweight and obese women with PCOS. We further compare the differences of PCOS and the controls with the methods of lipidomics, bile acid omics, proteomics and branched-chain amino acids, exploring the mechanisms of acupuncture on PCOS with this kind of methods.

Enrollment: 106 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: PCOS

• Age 20 to 40 years
• BMI≥ 24 to <40
• PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL.

Inclusion criteria: Controls

Controls should have BMI>25to<40, regular cycles with 28 days±2 days and no signs of hyperandrogenism and PCO morphology on ultrasound

Exclusion Criteria:

• Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
• Type I diabetes or not well controlled type II diabetes
• Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
• Pregnancy or breastfeeding the last 6 months
• Acupuncture last 3 months
• Daily smoking and alcoholic intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

active acupuncture + lifestyle management

Experimental group

Description:

Participants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment.

Treatment:

Other: Active acupuncture

Other: Lifestyle management

control acupuncture + lifestyle management

Sham Comparator group

Description:

Participants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment.

Treatment:

Other: Lifestyle management

Other: Sham acupuncture